BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAYFIELD BASE UNIT STD

    MDR report key: 2040370 · Received February 15, 2011

    Report

    Report Number
    3004608878-2011-00029
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    March 2, 2011
    Report Date
    March 15, 2011
    Manufacturer
    INTEGRA, CINCINNATI
    Product Code
    HBL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTEGRA LIFESCIENCES ENGINEERS HAVE COMPLETED A THOROUGH INVESTIGATION FOR THE RETURNED UNIT AND PROVIDED THE FOLLOWING INFO; THE UNIT WAS RECEIVED WITH THE SIX INCH TRANSITIONAL TEETH WORN AND NEEDED TO BE REPLACED, THE SHOCK CUSHION HAD MOVED FORWARD IN THE HANDLE AND WAS IMPEDING THE SIX INCH TRANSITIONAL FROM GOING INTO THE HANDLE; THE ADJUSTABLE WRENCH WAS BROKEN; THE SHOCK CUSHION WAS VERY WORN AND IS IMPEDING THE CAM ROD FROM BEING ADJUSTED PROPERLY. THIS UNIT WAS MFG AND PURCHASED DURING THE LAST QUARTER OF 1985 AND HAD NEVER BEEN SENT IN FOR ROUTINE MAINTENANCE. THE UNIT SHOULD NOT HAVE BEEN USED IN THE CONDITION IT WAS IN. ALL OTHER COMPONENTS WERE FUNCTIONAL. INTEGRA CONSIDERS THIS COMPLAINT INVESTIGATION CLOSED. FUTURE INCIDENTS OF THIS NATURE WILL BE DOCUMENTED FOR RECURRENCE AND TRENDING PURPOSES.

    Description of Event or Problem · 1

    AN ADULT PT (AGE UNSPECIFIED) WAS POSITIONED AND PINNED INTO THE MAYFIELD SKULL CLAMP FOR A POSTERIOR CERVICAL PROCEDURE. THE PT HAD NOT BEEN REPOSITIONED DURING THE PROCEDURE; HOWEVER, THE UNIT BEGAN TO GRADUALLY SLIDE DOWN TO THE POINT THAT IT WAS NECESSARY TO ADJUST THE UNIT THREE TIMES AND TAPE THE UNIT IN PLACE. THERE WAS NO INJURY AND NO DELAY IN THE PROCEDURE AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAYFIELD BASE UNIT STD BASE UNIT AND ADAPTERS HBL INTEGRA, CINCINNATI

    Patients

    Seq Age Sex Outcome Treatment
    1